Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003825

Trial Description

start of 1:1-Block title

Title

Evaluation of videotherapy after stroke using functional Magnetic Resonance Imaging

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Action observation is known to stimulate motor cortical structures. It is effective in improving motor skills in sports and music. It has been recommended to improve outcome after stroke.
The intention of our study was to evaluate 6 weeks of home based videotherapy after stroke.
Before discharge from our rehabilitation clinic patients reveived a DVD with motor tasks. They were asked to practice every day at home for six weeks. Clinical tests to assess hand function and a functional magnetic resonance imaging (fmri) were performed before and after the training.
There were two control groups. One group performed the same tasks every day according to a written instruction. They did not recieve any DVD. A second control group did not receive any speific home work. All patients were allowed to perform occupational and physical therapy as the house officer would prescribe.
Outcome parameter are clinical scores of hand function (Wolf Motor Function test, Nine Whole peg test) questionnaires concernig quality of live (Stroke Impact Scale) and BOLD signal changes in fmri.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Introduction: Action observation (AO) is propagated as attractive rehabilitation technique in stroke patients. It is not clear whether or not this technique is effective. Aim of our clinical study was to compare the effectiveness of a home based videotraining lasting for 6 weeks. In addition, we performed a functional magnetic resonance imaging (FMRI) study to shed light on the mechanisms involved in this new technique.

Subjects and methods:
Patients: patients with a hand paresis due to stroke. Ages ranging from 19 to 75.
Exclusion: Neglect, apraxia, dementia, aphasia, unwillingness to participate or to come to our hospital for reevaluation after the training.
Intervention: 6 weeks home based training. Patients received a DVD with motor tasks lasting for 1 hour. They were requested to practice every day one hour for 6 weeks.
Control groups: One group was requested to do the same motor tasks according to written instruction, without the videos. Another control group did not receive any spcific home work to do after discharge.
Outcome parameter: Hand and arm function as determined with Wolf Motor Function Test and Nine Hole Peg Test. Activity of daily living and stroke related quality of live detemined by the Stroke Impact Test.
Data acquisition: 1.5 T Philips Gyroscan NT.
Data analysis: Data converted to ANALYZE and analysed using SPM5 package. Main effects calculated and between-group differences determined in a mixed ANOVA (flexible factorial design analysis in SPM5).
Task: Subjects were asked to observe video clips during scanning or to imagine these actions from a first person perspective while looking at the video clips. Stimuli consisted of coloured video clips with simple, object-related hand actionsperformed with the right hand .

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003825
  •   2012/06/18
  •   [---]*
  •   no
  •   Approved
  •   keine Nummer vorhanden, Ethikkomission der Universität Konstanz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I61 -  Intracerebral haemorrhage
  •   I63 -  Cerebral infarction
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   homebased videotraining: At discharge patients receive a DVD. The DVD contains videos with individually selected motor tasks according to the individual level of impairment. Videos a selected from a collection of 45 videoclips, each lasting about 5 minutes. They display object related hand task of different task difficulty. After 45 seconds a voice says: Please start to imitate now and continue to practice. Patients are requested to practice 1 hour a day for six weeks.
  •   Patients receive a list and a description with the same motor tasks as group A. They are requested tp practice one hour every day for six weeks.
  •   The "usual care group" is discharged without any specific home work.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
  •   [---]*
  •   Active control, No treatment
  •   Treatment
  •   Parallel
  •   III
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Wolf Motor Function Test,
Nine Hole Peg test, Motor Activity Log (MAL),
Stroke Impact Scale (SIS).
All parameters are assessed before and after treatment.
Six monther after completion of the training patients recieve the SIS as questionnaire.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

BOLD signbal changes in fMRI before and after treatment.
It is analysed where plastic changes are demonstrated dependant on the treatment arm.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2008/08/01
  •   54
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

stroke patinets having a hand paresis
at least 4 weeks after the stroke onset
at least minimal hand function existing
sufficient communication and cognitive skills to cooprate and stable medical condition

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

clinically relevant aphasia, apraxia, neglect, dementia, major depression, psychiatric disease, epilepsia, arthritis, coma

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Lurija Instiut Stiftung Schmieder für Wissenschaft und Forschung, Allensbach
    • Postfach 240
    • 78473  Allensbach
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Kliniken Schmieder Konstanz
    • Mr.  Prof.Dr.  Christian  Dettmers 
    • Eichhornstr.68
    • 78464  Konstanz
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Kliniken Schmieder Konstanz
    • Mr.  Prof.Dr.  Christian  Dettmers 
    • Eichhornstr.68
    • 78464  Konstanz
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Lurija Institut Stiftung Schmieder für Wissenschaft und Forschung
    • Postfach 240
    • 78473  Allensbach
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2009/10/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.